Understanding Compounded Medications
Compounded sildenafil is prescribed under federal law but is not FDA-approved, meaning it does not undergo the same regulatory evaluation for safety, effectiveness, or manufacturing standards. Your healthcare provider at Good Medics may recommend a specific compounded sildenafil formulation based on your medical assessment and treatment needs.
Warning: Risks Associated with Sildenafil
Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor used for treating erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). While effective, sildenafil carries potential risks, particularly for individuals with pre-existing cardiovascular conditions. It is important to discuss the benefits and risks with your provider before starting treatment.
Sildenafil may cause a sudden drop in blood pressure, especially when taken with certain medications. Do not take sildenafil if you:
- Use nitrates for chest pain (such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate)
- Take guanylate cyclase stimulators such as riociguat (used for pulmonary hypertension)
- Have severe heart disease or have had a recent heart attack or stroke
What is Sildenafil Used For?
Sildenafil is used for:
- Erectile Dysfunction (ED): Helps achieve and maintain an erection by increasing blood flow to the penis.
- Pulmonary Arterial Hypertension (PAH): In certain cases, sildenafil is prescribed to improve exercise ability and reduce symptoms in individuals with PAH.
Limitations of Use
- Sildenafil does not protect against sexually transmitted infections (STIs).
- It should not be taken more than once per day.
- The effectiveness of sildenafil may be reduced by consuming excessive amounts of alcohol.
Who Should Not Use Sildenafil?
Do not take sildenafil if you:
- Use nitrate medications, as this combination can cause a dangerous drop in blood pressure.
- Have had a heart attack or stroke within the last six months.
- Have low blood pressure (hypotension) or uncontrolled high blood pressure.
- Have severe liver or kidney disease requiring dialysis.
- Have vision problems, including non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can lead to sudden vision loss.
- Are allergic to sildenafil or any of its components.
How to Take Sildenafil
Sildenafil is taken orally, with or without food. It can be used in two ways:
- As needed: Take approximately 30 to 60 minutes before sexual activity. It remains effective for up to 4 to 6 hours.
- Daily use (for PAH treatment): Take once per day as prescribed by your provider.
Do not exceed the prescribed dose. Consult your provider before changing your dosage.
What to Discuss with Your Provider Before Taking Sildenafil
Before starting sildenafil, inform your healthcare provider of all medications, supplements, and herbal products you are taking.
Medication Interactions:
- Nitrates and guanylate cyclase stimulators (e.g., nitroglycerin, riociguat) can cause severe low blood pressure.
- Alpha-blockers (used for high blood pressure or prostate conditions) may lead to excessive blood pressure reduction.
- Certain antifungal and antibiotic medications (such as ketoconazole, itraconazole, erythromycin, and clarithromycin) can impact sildenafil metabolism.
- HIV medications (such as ritonavir) can increase sildenafil levels in the body.
- Other PDE5 inhibitors (e.g., tadalafil, vardenafil) should not be taken alongside sildenafil.
Medical Conditions to Disclose
Before using sildenafil, tell your provider if you have or have had:
- Heart disease, irregular heartbeat, or heart failure
- Recent heart attack or stroke (within six months)
- High or low blood pressure
- Liver or kidney disease
- Blood disorders (sickle cell anemia, leukemia, multiple myeloma)
- Stomach ulcers or bleeding disorders
- Retinitis pigmentosa (a genetic eye disease)
- A history of sudden vision loss due to blood flow issues (NAION)
- Penile conditions such as Peyronie’s disease or priapism (prolonged erections)
Serious Side Effects
If you experience a medical emergency, call 911 immediately.
Serious side effects of sildenafil include:
- Heart attack or stroke symptoms (chest pain, shortness of breath, sudden weakness or numbness, slurred speech, vision changes)
- Sudden vision loss in one or both eyes (linked to NAION)
- Sudden hearing loss or ringing in the ears
- Prolonged or painful erections (priapism) lasting more than 4 hours
- Severe dizziness or fainting
- Severe allergic reactions (swelling of the face, lips, throat, difficulty breathing, rash)
Seek immediate medical attention if you experience these symptoms.
Common Side Effects
Common but less serious side effects include:
- Headache
- Flushing (redness or warmth in the face, neck, or chest)
- Indigestion or heartburn
- Nasal congestion
- Muscle or back pain
- Dizziness or lightheadedness
- Blurred vision or color vision changes
Use in Special Populations
- Older Adults: May be more sensitive to sildenafil’s effects, particularly its blood pressure-lowering properties.
- Pregnancy & Breastfeeding: Sildenafil is not for use in women unless prescribed for PAH.
Alcohol and Sildenafil
Drinking excessive alcohol while taking sildenafil may increase the risk of:
- Dizziness
- Low blood pressure
- Fainting
Monitoring and Follow-Ups
Regular check-ups are recommended to monitor:
- Heart and cardiovascular health
- Kidney and liver function
- Potential drug interactions
- Overall treatment effectiveness
Reporting Side Effects
If you experience side effects, report them to your healthcare provider or the FDA MedWatch program at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This document is not exhaustive. For complete safety information, refer to the official prescribing information or consult your healthcare provider.
